Prisoners and Clinical Trials

Much ink has been spilled over the Institute of Medicine's (IOM) recent recommendation to loosen federal restrictions on using prisoners as human subjects in medical research. Supporters point to the pharmaceutical and biomedical industry's growing need for participants in clinical trials, and to changing values among ethicists regarding autonomy and informed consent. Opponents highlight the legacy of past abuses and the likelihood that they will be repeated.

The Department of Health and Human Services commissioned the Institute of Medicine to "review the ethics regarding research involving prisoners . . . to explore whether [past] conclusions . . . remain appropriate today." Though the IOM makes several suggestions, the rubber meets the road in its recommendation to shift from the policy put in place in the 1970s, which severely limits clinical trials in prisons, to a more subjective risk/benefit analysis.

To justify this recommendation, the IOM changes the ethical framework governing prisoner participation as human subjects. The current framework, crafted to prevent repetitions of the serious abuses of past years, prioritizes justice - ensuring that prisoners are treated fairly in terms...